This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.

I. Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether > 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital or < 5% of patients die within 14 days of beginning outpatient chemotherapy.

OUTLINE:

Patients receive outpatient induction chemotherapy.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Signed written informed consent

The signed informed consent

The benefits / risks of the induction chemotherapy regimen will be reviewed, and a second consent may be necessary if the regimen will be administered according to a separate protocol

Treatment-related mortality (TRM) score < 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients

White blood cell (WBC) count =< 10,000

Fibrinogen > 200

Afebrile with a clear chest x-ray and no signs of active viral, bacterial, or fungal infection

Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) of 45% or greater, by multiple gated acquisition (MUGA) or echocardiogram

No ongoing cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart failure

Patient must have an outpatient caregiver available

Patient must live within 30 minutes of the treating physician's office during outpatient treatment

Patient must be willing to return to the treating physician's office for outpatient follow-up once outpatient treatment is completed

Logistical requirements:

Space available in infusion room

Outpatient infusion pump available if continuous infusion required

Case discussed with infusion room nursing staff

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01807091